Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06390345 · ClinicalTrials.gov registry record · NA
Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention
A NA study of Obstructive Sleep Apnea and Overweight and Obesity, sponsored by Seattle Institute for Biomedical and Clinical Research.
- Recruiting
- Registry status
- NA
- Development phase
- 400
- Enrollment target
- 5
- Study locations
NCT06390345 is a NA study of Obstructive Sleep Apnea and Overweight and Obesity that is actively recruiting participants, run by Seattle Institute for Biomedical and Clinical Research. The registered enrollment target is 400 participants, above the 219-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (83% higher). The trial reports 5 study locations across 4 states.
The verdict
NCT06390345, a NA study of Obstructive Sleep Apnea and Overweight and Obesity, is actively recruiting participants, sponsored by Seattle Institute for Biomedical and Clinical Research.
- RECRUITING
- Registry status
- NA
- Development phase
- 400 participants
- Enrollment target
- 5
- Study locations
Study Summary
The investigators will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). The investigators will include eligible participants receiving primary care at one of five Department of Veterans Affairs (VA) medical centers and their community-based outpatient clinics. The investigators will randomize patients in a 1:1 ratio to the multi-component intervention or "enhanced" usual care, stratifying by age (≥65 vs. \< 65) and site. Participants randomized to the intervention will receive an integrated, telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation. At the end of 3 months, the investigators will offer to enter a recommendation for weight management medications on behalf of eligible intervention participants. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach. For participants randomized to the "enhanced" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs. Follow-up will occur at virtual visits at 3 and 12 months. The primary effectiveness outcome at 1-year is quality of life measured by the SF-12 Physical Component Summary Score. Secondary effectiveness outcomes will include other measures of quality of life (including sleep related impairment), sleep disturbance, disease severity (COPD exacerbations and respiratory event index for OSA), depression, social support, weight loss and cardiovascular risk. In addition to assessing effectiveness, investigators will also conduct a concurrent implementation process evaluation using the RE-AIM framework.
Conditions Studied
Interventions
- OTHER Enhanced Usual Care
- OTHER FOCuSEd Integrated Intervention
Study Locations (5)
Washington
- VA Puget Sound Health Care System - Seattle
- Mann-Grandstaff VA Medical Center - Spokane
Idaho
- Boise VA Medical Center - Boise
Illinois
- Jesse Brown VA Medical Center - Chicago
Minnesota
- Minneapolis VA Health Care System - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2024-07-29 |
| Est. Completion | 2028-10-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06390345
The ClinicalTrials.gov registry entry for NCT06390345 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 219-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (83% higher). The listed sponsor is Seattle Institute for Biomedical and Clinical Research, which has 43 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 2 interventions - of which Enhanced Usual Care is the first listed.
NCT06390345 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Washington, Idaho, Illinois.
Frequently Asked Questions
What is clinical trial NCT06390345 about?
NCT06390345 is a clinical study titled "Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention". The investigators will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). The investigators will include eligible partici...
What is the current status of trial NCT06390345?
This trial is currently recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2024-07-29. Estimated completion is 2028-10-01.
What conditions does trial NCT06390345 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea, Overweight and Obesity, Chronic Obstructive Pulmonary Disease.
What interventions are being tested in trial NCT06390345?
The interventions under investigation include: Enhanced Usual Care (OTHER), FOCuSEd Integrated Intervention (OTHER).
Who is sponsoring clinical trial NCT06390345?
This trial is sponsored by Seattle Institute for Biomedical and Clinical Research, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06390345 being conducted?
This trial has 5 study locations across Idaho, Illinois, Minnesota, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obstructive Sleep Apnea
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
RECRUITING · NA
-
Cognition After OSA Treatment Among Native American People (CATNAP)
RECRUITING · NA
-
Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS)
RECRUITING · NA
-
Mandibular Advancement Device and Changes in Nocturia
RECRUITING · NA
-
Severe Label Expansion for EVO Products Trial
RECRUITING · NA
-
App-Based Optimization of Long-Term CPAP Adherence and Quality of Life
RECRUITING · NA
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.